Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria.

BACKGROUND: Persistent hemolytic anemia and a lack of oral treatments are challenges for patients with paroxysmal nocturnal hemoglobinuria who have received anti-C5 therapy or have not received complement inhibitors. Iptacopan, a first-in-class oral factor B inhibitor, has been shown to improve hemoglobin levels in these patients. METHODS: In two phase 3 trials, we assessed iptacopan monotherapy over a 24-week period in patients with hemoglobin levels of less than 10 g per deciliter. In the first, anti-C5-treated patients were randomly assigned to switch to iptacopan or to continue anti-C5 therapy. In the second, single-group trial, patients who had not received complement inhibitors and who had lactate dehydrogenase (LDH) levels more than 1.5 times the upper limit of the normal range received iptacopan. The two primary end points in the first trial were an increase in the hemoglobin level of at least 2 g per deciliter from baseline and a hemoglobin level of at least 12 g per deciliter, each without red-cell transfusion; the primary end point for the second trial was an increase in hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion. RESULTS: In the first trial, 51 of the 60 patients who received iptacopan had an increase in the hemoglobin level of at least 2 g per deciliter from baseline, and 42 had a hemoglobin level of at least 12 g per deciliter, each without transfusion; none of the 35 anti-C5-treated patients attained the end-point levels. In the second trial, 31 of 33 patients had an increase in the hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion. In the first trial, 59 of the 62 patients who received iptacopan and 14 of the 35 anti-C5-treated patients did not require or receive transfusion; in the second trial, no patients required or received transfusion. Treatment with iptacopan increased hemoglobin levels, reduced fatigue, reduced reticulocyte and bilirubin levels, and resulted in mean LDH levels that were less than 1.5 times the upper limit of the normal range. Headache was the most frequent adverse event with iptacopan. CONCLUSIONS: Iptacopan treatment improved hematologic and clinical outcomes in anti-C5-treated patients with persistent anemia - in whom iptacopan showed superiority to anti-C5 therapy - and in patients who had not received complement inhibitors. (Funded by Novartis; APPLY-PNH ClinicalTrials.gov number, NCT04558918; APPOINT-PNH ClinicalTrials.gov number, NCT04820530.).

Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.

BACKGROUND: The monoclonal antibody ublituximab enhances antibody-dependent cellular cytolysis and produces B-cell depletion. Ublituximab is being evaluated for the treatment of relapsing multiple sclerosis. METHODS: In two identical, phase 3, double-blind, double-dummy trials (ULTIMATE I and II), participants with relapsing multiple sclerosis were randomly assigned in a 1:1 ratio to receive intravenous ublituximab (150 mg on day 1, followed by 450 mg on day 15 and at weeks 24, 48, and 72) and oral placebo or oral teriflunomide (14 mg once daily) and intravenous placebo. The primary end point was the annualized relapse rate. Secondary end points included the number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) by 96 weeks and worsening of disability. RESULTS: A total of 549 participants were enrolled in the ULTIMATE I trial, and 545 were enrolled in the ULTIMATE II trial; the median follow-up was 95 weeks. In the ULTIMATE I trial, the annualized relapse rate was 0.08 with ublituximab and 0.19 with teriflunomide (rate ratio, 0.41; 95% confidence interval [CI], 0.27 to 0.62; P<0.001); in the ULTIMATE II trial, the annualized relapse rate was 0.09 and 0.18, respectively (rate ratio, 0.51; 95% CI, 0.33 to 0.78; P = 0.002). The mean number of gadolinium-enhancing lesions was 0.02 in the ublituximab group and 0.49 in the teriflunomide group (rate ratio, 0.03; 95% CI, 0.02 to 0.06; P<0.001) in the ULTIMATE I trial and 0.01 and 0.25, respectively (rate ratio, 0.04; 95% CI, 0.02 to 0.06; P<0.001), in the ULTIMATE II trial. In the pooled analysis of the two trials, 5.2% of the participants in the ublituximab group and 5.9% in the teriflunomide group had worsening of disability at 12 weeks (hazard ratio, 0.84; 95% CI, 0.50 to 1.41; P = 0.51). Infusion-related reactions occurred in 47.7% of the participants in the ublituximab group. Serious infections occurred in 5.0% in the ublituximab group and in 2.9% in the teriflunomide group. CONCLUSIONS: Among participants with relapsing multiple sclerosis, ublituximab resulted in lower annualized relapse rates and fewer brain lesions on MRI than teriflunomide over a period of 96 weeks but did not result in a significantly lower risk of worsening of disability. Ublituximab was associated with infusion-related reactions. (Funded by TG Therapeutics; ULTIMATE I and II ClinicalTrials.gov numbers, NCT03277261 and NCT03277248.).

Effects of electronic cigarettes and hookah (waterpipe) use on home air quality.

INTRODUCTION: A major site of secondhand smoke exposure for children and adults is the home. Few studies have evaluated the impact of e-cigarette or hookah use on home air quality, despite evidence finding toxic chemicals in secondhand e-cigarette aerosols and hookah smoke. We assessed the effect of e-cigarette and hookah use on home air quality and compared it with air quality in homes where cigarettes were smoked and where no smoking or e-cigarette use occurred. METHODS: Non-smoking homes and homes where e-cigarettes, hookah or cigarettes were used were recruited in the New York City area (n=57) from 2015 to 2019. Particulate matter with diameter less than 2.5 µm (PM2.5), black carbon and carbon monoxide (CO) were measured during a smoking or vaping session, both in a 'primary' smoking room and in an adjacent 'secondary' room where no smoking or vaping occurred. Log transformed data were compared with postanalysis of variance Tukey simultaneous tests. RESULTS: Use of hookah significantly increased PM2.5 levels compared with non-smoking homes, in both the primary and secondary rooms, while use of e-cigarettes increased PM2.5 levels only in primary rooms. Additionally, in-home use of hookah resulted in greater CO concentrations than the use of cigarettes in primary rooms. CONCLUSIONS: Use of e-cigarettes or hookah increases air pollution in homes. For hookah, increases in PM2.5 penetrated even into rooms adjacent to where smoking occurs. Extending smoke-free rules inside homes to include e-cigarette and hookah products is needed to protect household members and visitors from passive exposure to harmful aerosols and gases.

Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study.

Ravulizumab (ALXN1210), a new complement C5 inhibitor, provides immediate, complete, and sustained C5 inhibition. This phase 3, open-label study assessed the noninferiority of ravulizumab to eculizumab in complement inhibitor-naive adults with paroxysmal nocturnal hemoglobinuria (PNH). Patients with lactate dehydrogenase (LDH) ≥1.5 times the upper limit of normal and at least 1 PNH symptom were randomized 1:1 to receive ravulizumab or eculizumab for 183 days (N = 246). Coprimary efficacy end points were proportion of patients remaining transfusion-free and LDH normalization. Secondary end points were percent change from baseline in LDH, change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score, proportion of patients with breakthrough hemolysis, stabilized hemoglobin, and change in serum free C5. Ravulizumab was noninferior to eculizumab for both coprimary and all key secondary end points (Pinf < .0001): transfusion avoidance (73.6% vs 66.1%; difference of 6.8% [95% confidence interval (CI), -4.66, 18.14]), LDH normalization (53.6% vs 49.4%; odds ratio, 1.19 [0.80, 1.77]), percent reduction in LDH (-76.8% vs -76.0%; difference [95% CI], -0.83% [-5.21, 3.56]), change in FACIT-Fatigue score (7.07 vs 6.40; difference [95% CI], 0.67 [-1.21, 2.55]), breakthrough hemolysis (4.0% vs 10.7%; difference [95% CI], -6.7% [-14.21, 0.18]), and stabilized hemoglobin (68.0% vs 64.5%; difference [95% CI], 2.9 [-8.80, 14.64]). The safety and tolerability of ravulizumab and eculizumab were similar; no meningococcal infections occurred. In conclusion, ravulizumab given every 8 weeks achieved noninferiority compared with eculizumab given every 2 weeks for all efficacy end points, with a similar safety profile. This trial was registered at www.clinicaltrials.gov as #NCT02946463.

Nocturia and electrocardiographic abnormalities among patients at an inner-city cardiology clinic.

AIMS: Nocturia has been increasingly recognized as a potential manifestation of cardiovascular disease. However, the relationship between nocturia and electrocardiographic (ECG) abnormalities has not been studied. This study aims to characterize the diagnostic utility of nocturia in identifying left ventricular hypertrophy (LVH), left atrial enlargement (LAE), and prolonged QTc on ECG. METHODS: Retrospective analysis of nocturnal voiding frequency and contemporaneous ECG data from consecutive patients evaluated at a university-based outpatient cardiology clinic. Three sets of three incremental binary multiple logistic regression models controlling for (1) age, (2) sex and race, and (3) body mass index, hypertension, diabetes mellitus, and diuretic utilization were performed to determine whether nocturia was predictive of LVH, LAE, and prolonged QTc. RESULTS: Included patients (n = 143, 77.6% nocturia) were predominantly African-American (89.5%), female (74.1%), and obese (61.5%), of whom 44.1%, 41.3%, and 27.3% had LVH, LAE, and prolonged QTc, respectively. Older age, African-American race, obesity, hypertension, diuretic use, LVH, and LAE were significantly associated with nocturia on univariate analysis. No significant differences were observed in the strength of associations between nocturia and LVH, LAE, or QTc prolongation based on age. Nocturia independently predicted LVH in Models I-III (odds ratios [ORs], 2.99-3.20; relative risks [RRs], 1.18 for all, p ≤ .046) and LAE in Models I-III (ORs, 4.24-4.72; RRs, 1.21 for all, p ≤ .015). No significant associations were observed between nocturia and prolonged QTc. CONCLUSIONS: Nocturia may be a risk marker for underlying structural cardiac abnormalities.

Accuracy of Blood Transfusion Records in a Population-based Perinatal Data Registry.

BACKGROUND: Blood transfusion is frequently used as an indicator of severe maternal morbidity during pregnancy. However, few studies have examined its validity in population perinatal databases. METHODS: We linked a perinatal database from British Columbia, Canada, with the province's Central Transfusion Registry for 2004-2015 deliveries. Using the Central Transfusion Registry records for red blood cell transfusion as the gold standard, we calculated the sensitivity, specificity, positive predictive value, and negative predictive value of the perinatal database variable for red blood cell transfusion, overall and by transfusion risk factor status. We used multivariable logistic regression to examine whether outcome misclassification altered the odds ratios for different transfusion risk factors. RESULTS: Among 473,688 deliveries, 4,033 (8.5 per 1,000) had a red blood cell transfusion according to the Central Transfusion Registry. The sensitivity of the perinatal database transfusion variable was 72.3 [95% confidence interval (CI) = 72.2, 72.4]. Sensitivity differed according to the presence of many transfusion risk factors (e.g., 84.9% vs. 72.2% in deliveries with versus without uterine rupture). Odds ratios associated with some transfusion risk factors were exaggerated when the perinatal database transfusion variable was used to define the outcome instead of the Central Transfusion Registry variable, but 95% confidence intervals for these estimates overlapped. CONCLUSION: Blood transfusion was documented with reasonable sensitivity in this large population perinatal database. However, validity varied according to risk factor status. Our findings enable researchers to better account for outcome misclassification in studies of obstetrical transfusion risk factors.

Impaired proteostasis in senescent vascular endothelial cells: a perspective on estrogen and oxidative stress in the aging vasculature.

The heat shock response is an important cytoprotective mechanism for protein homeostasis and is an essential protective response to cellular stress and injury. Studies on changes in the heat shock response with aging have been mixed with regard to whether it is inhibited, and this, at least in part, reflects different tissues and different models. Cellular senescence is a key feature in aging, but work on the heat shock response in cultured senescent (SEN) cells has largely been limited to fibroblasts. Given the prevalence of oxidative injury in the aging cardiovascular system, we investigated whether SEN primary human coronary artery endothelial cells have a diminished heat shock response and impaired proteostasis. In addition, we tested whether this downregulation of heat shock response can be mitigated by 17ß-estradiol (E2), which has a critical cardioprotective role in women, as we have previously reported that E2 improves the heat shock response in endothelial cells (Hamilton KL, Mbai FN, Gupta S, Knowlton AA. Arterioscler Thromb Vasc Biol 24: 1628-1633, 2004). We found that SEN endothelial cells, despite their unexpectedly increased proteasome activity, had a diminished heat shock response and had more protein aggregation than early passage cells. SEN cells had increased oxidative stress, which promoted protein aggregation. E2 treatment did not decrease protein aggregation or improve the heat shock response in either early passage or SEN cells. In summary, cellular senescence in adult human endothelial cells is accompanied by increased oxidative stress and a blunting of proteostasis, and E2 did not mitigate these changes. NEW & NOTEWORTHY Senescent human endothelial cells have a diminished heat shock response and increased protein aggregates. Senescent human endothelial cells have increased basal oxidative stress, which increases protein aggregates. Physiological level of 17ß-estradiol did not improve proteostasis in endothelial cells.

Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE.

BACKGROUND: STRIVE is a multicenter, observational, open-label, single-arm study of natalizumab in anti-JC virus (JCV) seronegative patients with early relapsing-remitting multiple sclerosis (RRMS). The objective of this prespecified 2-year interim analysis was to determine the effectiveness of natalizumab in establishing and maintaining no evidence of disease activity (NEDA) in early RRMS. METHODS: Patients aged 18-65 years had an RRMS diagnosis < 3 years prior to screening, an Expanded Disability Status Scale (EDSS) score ≤ 4.0, and anti-JCV antibody negative status. Magnetic resonance imaging was performed at baseline and yearly thereafter. Cumulative probabilities of 24-week-confirmed EDSS worsening and improvement were evaluated at 2 years. NEDA (no 24-week-confirmed EDSS worsening, no relapses, no gadolinium-enhancing lesions, and no new/newly enlarging T2-hyperintense lesions) was evaluated over 2 years. The Symbol Digit Modalities Test (SDMT) and Multiple Sclerosis Impact Score (MSIS-29) were assessed at baseline and 1 and 2 years. Statistical analysis used summary statistics and frequency distributions. RESULTS: The study population (N = 222) had early RRMS, with mean (standard deviation [SD]) time since diagnosis of 1.6 (0.77) years and mean (SD) baseline EDSS score of 2.0 (1.13). NEDA was achieved in 105 of 187 patients (56.1%) during year 1 and 120 of 163 (73.6%) during year 2. Over 2 years, 76 of 171 patients (44.4%) attained overall NEDA. Probabilities of 24-week-confirmed EDSS worsening and improvement were 14.1% and 28.4%, respectively. After 2 years, patients exhibited significant improvements from baseline in SDMT (n = 158; mean [SD]: 4.3 [11.8]; p < 0.001) and MSIS-29 physical (n = 153; mean [SD]: - 3.9 [14.7]; p = 0.001), psychological (n = 152; mean [SD]: - 2.0 [7.9]; p < 0.001), and quality-of-life (n = 153; mean [SD]: - 6.0 [21.3]; p < 0.001) scores. CONCLUSIONS: These results support natalizumab's effectiveness over 2 years, during which nearly half of early RRMS patients achieved NEDA. During year 2, nearly 75% of patients exhibited NEDA. Over 2 years, patients continued to experience significant cognitive and quality-of-life benefits. These results are limited by the lack of a comparator group to determine the extent of a placebo effect. TRIAL REGISTRATION: clinicaltrials.gov, NCT01485003 , registered 5 December 2011.

Evaluating State-Level Differences in E-cigarette and Cigarette Use Among Adults in the United States Between 2012 and 2014: Findings From the National Adult Tobacco Survey.

Objective: To examine the association between state-level tobacco control measures and current use estimates of both e-cigarettes and cigarettes, while accounting for socio-demographic correlates. Methods: Using the 2012-2013 and 2013-2014 National Adult Tobacco Survey (NATS), we assessed prevalence estimates of US adults' e-cigarette and cigarette current use. Four state groups were created based on the combined state-specific prevalence of both products: low cigarette/e-cigarette (n = 15), high cigarette/e-cigarette (n = 16), high cigarette/low e-cigarette (n = 11), and low cigarette/high e-cigarette) (n = 9). To evaluate the implementation of state-level tobacco control measures, Tobacco Control Index (TCI) was calculated using the State of Tobacco Control annual reports for 2012 and 2013. Multinomial logistic regression models were used to examine differences among the four groups on socio-demographic factors and TCI. Low cigarette/e-cigarette group was used as the referent group. Results: Current use estimates of each product varied substantially by state; current e-cigarette use was highest in Oklahoma (10.3%) and lowest in Delaware (2.7%), and current cigarette use was highest in West Virginia (26.1%), and lowest in Vermont (12.6%). Compared to low cigarette/e-cigarette, all other US-state categories had significantly lower TCI scores (high cigarette/e-cigarette: adjusted Relative Risk Ratio [aRRR] = 0.61; 95% confidence interval [CI]: 0.60-0.61, high cigarette/low e-cigarette: aRRR = 0.74; 95% CI: 0.73-0.74, and low cigarette/high e-cigarette: aRRR = 0.72; 95% CI: 0.71-073). Conclusions: Enforcing existing tobacco control measures likely interacts with e-cigarette use despite being cigarette-focused. Continuing to monitor e-cigarette use is critical to establish baseline use and evaluate future e-cigarette specific federal and state-level tobacco regulatory actions while accounting for the existing tobacco control environment. Implications: This study investigates state-level current use estimates of e-cigarettes and cigarettes among US adults; and their association with four existing tobacco control measures. The overall score of these measures was negatively associated with state-level current use estimates such that states with low current e-cigarette and cigarette use had the highest mean overall score. This study assesses the potential relationship between existing state-level tobacco control measures and e-cigarette use and calls for improving the enforcement of the known-to-work tobacco control measures across all US states, while developing evidence-based regulations and interventions specific to e-cigarettes within the existing US tobacco use environment.

Salivary cotinine concentration and carbon monoxide levels in young adults smoking midwakh in comparison with cigarette smokers.

OBJECTIVES: To estimate and compare the salivary cotinine levels using a semiquantitative method, called NicAlert, between three groups: non-smokers, daily smokers of cigarettes and daily smokers of midwakh, and to compare the carbon monoxide (CO) levels among these groups. MATERIALS AND METHODS: A total of 159 adult male volunteers aged 20 and above were included, with 54 current cigarette smokers, 52 current midwakh smokers and 53 non-smokers. Estimate of breath carbon monoxide and salivary cotinine were collected, as well as sociodemographic characteristics and details of smoking habits and second-hand smoke exposure among participants. Institutional review board approval was obtained and data were analysed using SPSS V.21 with the Kruskal-Wallis test used to obtain differences in the distribution. RESULTS: There was no significant difference in the median breath CO and salivary cotinine levels between cigarette and midwakh smokers. Levels of breath CO were significantly higher in cigarette and midwakh smokers as compared with non-smokers (19.5, 17.5 and 6.0, respectively, p<0.05); the same relationship was observed for cotinine levels among cigarette and midwakh smokers as compared with non-smokers (4.0, 3.0 and 0.0, respectively, p≤0.05). Additionally, the values of both salivary cotinine and breath CO increased with the frequency of tobacco use. CONCLUSION: These are the first data that we are aware of that demonstrate that in terms of at least two key biomarkers of tobacco use, there are comparable levels of exposure between cigarettes and midwakh users, demonstrating a need for intensified attention to the use of midwakh.

Living in immigrant communities does not impact total knee arthroplasty outcomes: experience from a high-volume center in the United States.

BACKGROUND: Community characteristics such as poverty affect total knee arthroplasty (TKA) outcomes. However, it is unknown whether other community factors such as immigrant proportion (IP) also affect outcomes. Our objective was to determine the association of neighborhood IP on preoperative (pre-op) and 2-year postoperative (post-op) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function after elective TKA. METHODS: Patients in a high volume institutional TKA registry between May 2007 and February 2011 were retrospectively analyzed. Demographics, pre-op and 2-year post-op WOMAC pain and function scores, and geocodable addresses were obtained. Patient-level variables were linked to US Census Bureau census tract data. The effect of patient and neighborhood-level factors on WOMAC scores were analyzed using linear mixed effects models. RESULTS: 3898 TKA patients were analyzed. Pre-op and 2-year post-op WOMAC pain and function scores were between 2.75-4.88 WOMAC points worse in neighborhoods with a high IP (≥ 40%) compared to low IP (< 10%). In multivariable analyses, these differences were not statistically significant. Women had worse pre-op and 2-year post-op WOMAC scores (all p ≤ 0.04), but this difference was not influenced by neighborhood IP (all pinteraction NS). CONCLUSIONS: Patients living in high (≥40%) IP neighborhoods do not have worse pre-op or 2-year post-op pain and function outcomes after TKA compared to those living in low (< 10%) IP neighborhoods. Although sex differences favoring males are notable, these differences are not associated with IP. High neighborhood IP do not appear to affect outcomes after TKA.

Age-Related Functional Decline Following Total Knee Arthroplasty: Risk Adjustment is Mandatory.

BACKGROUND: Patient-reported outcome measures (PROMs) are being used increasingly to determine the success of total knee arthroplasty (TKA). Our goal is to investigate whether advanced age is associated with lower PROM scores. METHODS: We used our hospital's TKA registry to examine the relationship between age and PROMs in all patients 50-90 years of age who underwent unilateral or simultaneous bilateral primary TKA between 2007 and 2011 with a primary diagnosis of osteoarthritis. All 5 domains of the Knee Injury and Arthritis Outcomes Score (KOOS) and the Lower Extremity Activity Scale (LEAS) at baseline, 2 years, and 5 years were collected. The association between age and PROM score was assessed by piecewise linear regression using generalized estimating equations, adjusting for demographics, comorbidity, and baseline score. RESULTS: Significant nonlinear relationships among age, KOOS subdomains, and LEAS were found. The placement of the age spline knot was at 70 years for KOOS Symptom and 68 years for KOOS Pain, KOOS Activities of Daily Living (ADL), and LEAS. The KOOS Symptom domain showed a significant worsening between 2-year and 5-year follow-up (P < .05) as patients got older. CONCLUSION: We found an age-related decline in KOOS Pain, KOOS Symptom, KOOS ADL, and LEAS scores. The best fitting spline knots were at 68 (KOOS Pain, KOOS ADL, and LEAS) and 70 years (KOOS Symptoms), respectively. This demonstrates that there is a critical age at which functional decline begins regardless of the quality of the TKA surgery. Our findings will help surgeons accurately guide patient expectations after TKA based on age. LEVEL OF EVIDENCE: Level II, prognostic study.

Experiences of Chinese immigrant women following "Zuo Yue Zi" in British Columbia.

AIMS AND OBJECTIVES: To describe Chinese women's experiences with "zuo yue zi" in British Columbia, Canada. BACKGROUND: Women born in China and Taiwan are increasingly immigrating to westernised countries. Many women choose to follow traditional Chinese postpartum practices, also called "zuo yue zi." Few studies have examined women's use of traditional practices in western countries. DESIGN: The study used a qualitative descriptive design. METHODS: We recruited 13 mothers who were: aged 19 or older, immigrants from mainland China, Hong Kong or Taiwan in the last 5 years, and caring for infants born in the previous 6 weeks. Semistructured interviews were conducted in Mandarin, translated into English, transcribed and analysed using inductive content analysis. RESULTS: The core theme was Chinese women's novel encounters with "zuo yue zi." The women's expectations of "zuo yue zi" were acquired through birth experiences or interactions with family and friends. The participants struggled with implementing traditional practices because social support and formal institutional structures were lacking. They modified their expectations about "zuo yue zi." Factors affecting their practices were catalysts and deterrents. Catalysts included help from Chinese family members, friends and informed healthcare providers. Deterrents included unregulated paid helpers, uninformed care providers, financial constraints and structural limitations in their new environments. CONCLUSIONS: Chinese immigrant women struggled to modify and implement traditional practices in their adopted country when they encountered financial constraints, unregulated paid helpers and varying support from health care providers. RELEVANCE TO CLINICAL PRACTICE: Some postpartum women following "zuo yue zi" believed that the practice would prevent chronic illness and strengthen their intrafamily relationships. Immigrant mothers require nursing support to follow traditional postpartum practices. Nurses can advocate on patients' behalf to increase care providers' knowledge about "zuo yue zi" and public awareness for necessary regulated institutional structures.

Safety of labour and delivery following closures of obstetric services in small community hospitals.

BACKGROUND: In recent decades, many smaller hospitals in British Columbia, Canada, have stopped providing planned obstetric services. We examined the effect of these service closures on the labour and delivery outcomes of pregnant women living in affected communities. METHODS: We used maternal postal codes to identify delivery records (1998-2014) of women residing in a community affected by service closure. The records were obtained from the British Columbia Perinatal Data Registry. We examined the effect of the closures using a within-communities fixed-effects framework and included similar-sized communities without service closures to control for underlying time trends. The primary outcome was a previously published composite measure of labour and delivery safety, the Adverse Outcome Index, which includes adverse events such as birth injury and unanticipated operative procedures, and includes weights for severity of adverse events. Secondary outcomes included maternal or newborn transfer, and use of obstetric interventions. RESULTS: We found little evidence that closure of planned obstetric services affected the risk of composite adverse maternal-newborn outcome (-0.4 excess adverse events per 100 deliveries, 95% confidence interval [CI] -2.0 to 1.1), or most other secondary outcomes. The severity of composite outcome events decreased following the closures (rate ratio 0.58, 95% CI 0.36 to 0.89). Closures were associated with increases in use of epidural analgesia (3.4 excess events per 100 deliveries, 95% CI 0.4 to 6.3) and length of antepartum stay (0.6 h, 95% CI 0.1 to 1.0 h). INTERPRETATION: Closure of planned obstetric services in low-volume hospitals was not associated with an increase or decrease in frequency of adverse events during labour and delivery.

Analysis of State-Specific Prevalence, Regional Differences, and Correlates of Hookah Use in U.S. Adults, 2012-2013.

OBJECTIVE: To investigate the state-specific prevalence, regional differences, and correlates of hookah use among U.S. adults. METHODS: We analyzed the most recent nationally representative data of adults from the National Adult Tobacco Survey (NATS) 2012-2013 (n = 60192). State-specific prevalence of lifetime and current hookah use was calculated and mapped. Multivariate logistic regression was performed to determine the association between sociodemographic characteristics, regional differences, and hookah use. RESULTS: Among U.S. adults (≥18 years), overall prevalence of lifetime hookah use was 12.3%, while current use was 3.9%. Mapping of state-specific prevalence revealed that the West tended to have higher rates of use, while the South tended to have lower ones. In the adjusted model, we observed that current hookah use was positively associated with younger adults, males, non-Hispanic adults, those with higher education and income statuses, being single, those living in the West, and current cigarette use. CONCLUSION: The prevalence of hookah use varies by state, region, and sociodemographic characteristics among adults. Future research, including longitudinal studies, are needed to identify geographic and sociodemographic characteristics and trends among hookah users, investigate hookah-related health outcomes, and evaluate targeted public health efforts aimed at this emerging threat. IMPLICATIONS: This study investigates state-level prevalence, regional differences, and sociodemographic characteristics of hookah use among U.S. adults, using the most recent NATS. Hookah use was positively associated with younger adults and those living in the West. This study adds to the understanding of the geographic and sociodemographic factors underlying hookah use, which can be used to develop much needed evidence-based regulations and programs that are responsive to the needs of different risk groups.

The Difference a Decade Makes: Smoking Cessation Counseling and Screening at Pediatric Visits.

INTRODUCTION: There has been a sharp decline in adolescents who smoke cigarettes but no national-level study evaluating the impact of smoking cessation counseling by pediatricians or other clinicians who care for children. METHODS: Combined data from ambulatory portions of the National Hospital Ambulatory Care Survey and National Ambulatory Medical Care Survey from 1997-1999 and 2009-2011 were analyzed to determine changes in the frequency of pediatric visits that included clinician-reported tobacco counseling and how such counseling varied by child, family, and clinician characteristics. RESULTS: In 1997-1999, 1.5% of all medical visits for children aged below 19 years included tobacco counseling; this increased to 3.8% in 2009-2011 (P < .001). A marked increase from 4.1% to 11.1% was noted at well-child visits (P < .001). There were significant increases in counseling by pediatricians but not mid-level providers or general/family physicians. Provision of counseling did not result in greater visit length during either time point. During 2009-2011, visits with a diagnosis of asthma were four times as likely (OR 4.2, 95% CI 2.8-6.2) and visits for otitis media two times as likely (OR 2.1, 95% CI 1.2-3.7) to include smoking cessation counseling than sick visits for all other diagnoses. CONCLUSION: These results demonstrate a significant increase in tobacco counseling by pediatric providers within the last decade, especially at well-child visits. However, the American Academy of Pediatrics' recommendation that pediatricians counsel about the harms of tobacco use and secondhand smoke exposure has not yet been exhaustively implemented. IMPLICATIONS: A significant increase in smoking cessation counseling at pediatric medical appointments, especially at well-child visits, occurred from 2009-2011 compared with 1997-1999, paralleling a large decrease in smoking prevalence. These improvements in counseling rates have been predominantly noted for pediatricians but not mid-level providers or general practitioners. Counseling was not associated with increased visit lengths. Although improved counseling practices by pediatricians have been demonstrated, there is still room for improvement.

Effects of hookah smoking on indoor air quality in homes.

INTRODUCTION: Hookahs (water pipes) are rapidly increasing in popularity worldwide. Evidence suggests that although perceived as safer than cigarette smoke, hookah smoke may be as, or even more, dangerous as cigarette smoke. METHODS: Air samples from 33 homes-11 where only hookah-smoking occurred, 12 with only cigarettes and 10 with no smoking-were collected to analyse concentrations of particulate matter (PM2.5), black carbon, elemental and organic carbon and carbon monoxide (CO). Air quality was assessed in rooms where smoking occurred and in an adjacent room. RESULTS: Hookah and cigarette smoking impaired home air quality. The rooms in which hookahs were smoked showed the highest concentrations for all pollutants. CO was significantly greater in the rooms where hookahs were smoked than in the cigarette-smoking rooms and the non-smoking households (p<0.05). In addition, CO levels in the rooms adjacent to where hookah was smoked were 2.5-fold to 4-fold greater than those in the smoking and non-smoking rooms of the cigarette homes (p<0.05). PM2.5 levels were also elevated in hookah homes compared to cigarette and non-smoking homes, although not significantly different. CONCLUSIONS: This study, the first of its kind, demonstrates potentially hazardous levels of home air pollution in rooms where hookahs are being smoked as well as in adjacent rooms. These levels were greater than those in cigarette smoking homes, raising concerns about potential negative health effects on all individuals living in homes where hookahs are smoked.

Management of Spontaneous Labour at Term in Healthy Women.

OBJECTIVE: The purpose of this guideline is to provide guidance for the intrapartum management of spontaneous labour, whether normal or abnormal, in term, healthy women, and to provide guidance in the management of first and second stage dystocia to increase the likelihood of a vaginal birth and optimize birth outcomes. EVIDENCE: Published literature was retrieved through searches of PubMed and the Cochrane Library in October 2011 using appropriate, controlled vocabulary (e.g., labour pain; labour, obstetric; dystocia) and key words (e.g., obstetric labor, perineal care, dysfunctional labor). When appropriate, results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Results were limited to the last 10 years. Searches were updated on a regular basis and incorporated in the guideline up to June 15, 2015. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). SUMMARY STATEMENTS: RECOMMENDATIONS.

Prise en charge du travail spontané chez les femmes en santé, à terme.

OBJECTIF: La présente directive vise à fournir des conseils concernant la prise en charge du travail spontané intrapartum, normal ou anormal, à terme, chez les femmes en santé, ainsi que des conseils relatifs à la prise en charge de la dystocie lors du premier et du deuxième stade du travail, pour favoriser l'accouchement vaginal et optimiser les issues de la grossesse. DONNéES PROBANTES: Des documents publiés ont été récupérés au moyen de recherches effectuées dans PubMed et la Cochrane Library, en octobre 2011, à partir d'une terminologie appropriée et contrôlée (p. ex., labour pain; labour, obstetric; dystocia) et de mots-clés (p. ex., obstetric labor, perineal care, dysfunctional labor). Lorsque cela convenait, on n'a tenu compte que des résultats qui proviennent de revues systématiques, d'essais contrôlés aléatoires ou d'essais cliniques contrôlés et d'études d'observation. Seuls les résultats des 10 dernières années ont été pris en considération; les recherches ont été régulièrement mises à jour jusqu'au 15 juin 2015 et intégrées à la directive. VALEURS: La qualité des données probantes a été évaluée en fonction des critères décrits dans le Rapport du Groupe d'étude canadien sur les soins de santé préventifs (tableau 1). DéCLARATIONS SOMMAIRES: RECOMMANDATIONS.